In a far-reaching judgment that could have major implications for the biotech industry, a federal judge in Manhattan has struck down patents related to two human genes linked to hereditary breast and ovarian cancers, BRCA1 and BRCA2.

Myriad Genetics held the patents, and women who want to find out if they have a high genetic risk for these cancers have to get a test sold by Myriad, which costs more than $3,000. Plaintiffs in the case had said Myriad’s monopoly on the test, conferred by the gene patents, kept prices high and prevented women from getting a confirmatory test from another laboratory [The New York Times]. In his decision, United States District Court Judge Robert W. Sweet found that the company’s patents were invalid because the genes are “found in nature,” and products of nature can’t be patented. In essence, he agreed with the plaintiffs’ argument that the genetic code contained in each human being’s cells shouldn’t be private property.

Tuesday’s decision, if upheld, could have wide repercussions for the multi-billion dollar biotech industry, which is built on more than 40,000 gene patents. Already, about 20 percent of the human genes have been patented. The decision, however, is not binding on other federal courts and other judges may or may not abide by it. But it does the set the stage for years of litigation over other gene patents. Myriad Genetics plans to appeal the judgment.

As DISCOVER reported earlier this year, the case was brought to court by the American Civil Liberties Union (ACLU) on behalf of 20 plaintiffs, including the American College of Medical Genetics, the Association for Molecular Pathology, and various individuals. The lawsuit charged that the BRCA patents—and gene patents in general—violate established laws that prohibit the patenting of products and laws of nature. According to the ACLU, “Human genes, even when removed from the body, are still products of nature” [DISCOVER]. The plaintiffs alleged that the company’s patents also prevented research on the genes and their link to cancer, and was ultimately harmful in the long run.

However,Myriad Genetics, the company that holds the patents with the University of Utah Research Foundation argued that the case held no merit as the work of isolating the DNA from the body transforms it and makes it patentable [The New York Times]. Patents like this, the company maintained, had been granted for decades. Judge Sweet however, shot down that argument and maintained that the previous patents were “improperly granted.” He said that many critics of gene patents considered the idea that isolating a gene made it patentable “a ‘lawyer’s trick’ that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result” [The New York Times].

Calling the decision a “victory for the free flow of ideas in scientific research,” the ACLU said the human genome “was discovered, not created. There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas” [Newsweek]. However, experts who sided with Myriad said that if the decision was upheld, it would have a significantly hold back medical research, as new companies would have trouble raising money from investors for their research.

Here’s what the other biotech companies who have been watching the case closely need to know: The decision won’t affect their patents at this point, and experts say the U.S. Patent and Trademark Office isn’t likely to change its rules on gene patenting because of this decision. But the lawsuits have no doubt just begun.

I don’t know how I feel about this. Obviously the idea that somebody could own the rights to a particular sequence of DNA are absurd, but the only reason we’re sequencing at all (and in turn the only reason we’re discovering the exact sequences of genes and how they affect us) is because of the promise of wealth for the people and companies who do it. I don’t know which way I want this to go: the ruling that upholds the right for everybody to get cured at a fair price, or the ruling that encourages people to find the cures.

Matt T

How about something similar to the (wildly successful) pharma patenting process? A company can sequence genes and “own” them for a short time in order to recoup costs, presumably by administering treatments based on that “discovered information”. Then, after a prescribed amount of time, the discovered information is made public so that other companies can provide the same or similar treatment at lower cost. I may be way off on how the pharmaceutical process works, but I think this could work for genes.

Tom Waite

Doug is wrong. The reason the DNA was sequenced in the first place is because of everyone’s tax dollars. The Human Genome Project was paid for by our government, by you and me. In the specific case of Myriad Genetics, the BRCA genes were identified as a part of NIH sponsored research, also paid for 100% by our tax dollars.

The lawsuit aims to set a basic outline for what kinds of developments constitute patents. Products of Nature (i.e. things you find that exist already in nature) are historically not patentable. You can’t patent a rock, but you CAN patent a process for modifying that rock, or an invention that you create that uses a rock as one of its components.

With regards to gene patents, the idea would be that the gene itself should not be patentable, but any specific drug or assay using that gene could be patented. This would enable specific testing methods and drugs to be patentable, but would also allow competition from other companies. Currently there is no competition at all because Myriad Genetics is the only company in the United States that is allowed to sequence your BRCA genes. If you want a second opinion, where can you go? Nowhere.

Imagine that! DNA sequencing technology has been around for half a century, and the human genome sequence was developed purely through US tax dollars. But somehow you’re not allowed to use any type of DNA sequencing technology or assay of any kind to look at the information in your own cells??? If I wanted to start a company to use 50 year old technology to read the publically available sequence of people for money, I’d be sued by 20,000 different companies! Currently it costs about 5,000 to 10,000 to sequence an entire human genome, but if I was going to pay the licensing or sequencing fees of all these companies, it would cost $30,000,000!

This is madness, and it’s not what we typically think of as an acceptable definition of a patent in other areas of science or business.

Each person’s genome is their own property, there is nothing more individual or personal than your own genetics. If you want to get it sequenced, it’s your right. If you want to get it sequenced by a particular patented method, then you have to pay that company, and let the companies compete on price and data quality. But nobody owns my genes, and you shouldn’t let yourself be convinced that anyone owns yours either.

Tom Waite, MD-PhD
New York, NY

BenJ

I have no qualms whatsoever about erasing all of these gene patents. Biotech companies should make money (via patents) on their “novel treatments and techniques” not on the “knowing gene xyz exists.”

Treatment techniques are NOT required to obtain these gene patents.

The point is that gene patents actually make innovative techniques acting on the same gene difficult/expensive/impossible.

Avi

While you can’t patent a gene, I wonder if you could possibly patent primers that flank the gene. That would have a similar end result and would get around this new ruling.

http://tispaquin.blogspot.com Doug Watts

If the “owners” of defective gene segments (say, that lead to breast cancer) want to be responsible for the effect of these patented genes on people, and thereby become financially liable for the effect of the “their” genes on peoples’ health, then by all means, full steam ahead.

Ryan

I think Matt T is onto something. It just strikes me as absurd that somehow sequencing genes imbues ownership. What Matt suggested ensures the genes remain public property while providing incentive for private companies to do the legwork of figuring out how to make the information medically useful.

Tom

No one should be able to patent life or anything that occurs in nature. The potential for abuse is staggering. We would have to pay these companies just to live.
That being said, based on Tom Waite’s information, which to my knowledge is accurate, we paid for the research that led to these discoveries. Therefore, shouldn’t the taxpayers own any potential patents that have arisen due to said research?

Illusions

Bravo Tom Waite. That is absolutely the truth. What I find intriguing is the fact that business interests are so capable of selling the idea that it will be harmful to us to make them act according to the law and any reasonable legal standards. “If you dont allow us to profit ridiculously, you wont have access to x, y, z, technology.” Even if that were the case, we could subsidize that along with all the other public goods that are unprofitable. I would rather that than have my DNA belong to someone else, and have to pay who knows what ransom to access it.

I am glad you pointed out that the public dime funded that research. As it often does. And you are right, the potential for abuse in enormous. Good job. Although I do like Doug Watts idea that since they think they “own” the gene, perhaps they should be liable for its actions.

Philip

There’s a fascinating take on this at the Skeptic’s Health Journal, sort of provides some of the background to the debate, if interested you can read on it here, http://healthjournalclub.blogspot.com/

Dov Henis

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Providing the SERVICE of treating disease is the money generator and needs to be the focus for incentive to continue research. Patent the process. Owning a patent on a genome is ridiculous and absurd and completely counter-intuitive. It’s a gene … it ALREADY EXISTS. You might as well patent all the letters in the alphabet, or a raincloud. These bio-businesses need to be put in their place and get back to understanding what they are in business for. it’s NOT just about making money … but of course, that’s what the American system can only seem to focus on.